Why Shares of BioXcel Therapeutics Are Plunging Thursday
Shares of BioXcel Therapeutics (NASDAQ: BTAI) were down 62% at 11 a.m. on Thursday after the company announced phase 3 trial results for Alzheimer's disease–related agitation therapy BXCL501. The stock is down more than 68% so far this year.
BioXcel is a biotech company that uses artificial intelligence to find neurological and immuno-oncological therapies. On Thursday, before the markets opened, it announced positive top-line results for a phase 3 trial for BXCL501, a oral film formulation of dexmedetomidine, to treat agitation in Alzheimer's patients. The company said the therapy met its primary efficacy endpoint with a better result after two hours than a placebo on the Positive and Negative Syndrome Scale, Excitatory Component (PEC).
However, according to Reuters, the company said one trial site's lead investigator was found to have fabricated emails related to the timing of a serious side effect with the company's vendor that was responsible for monitoring the safety of the drug. The Food and Drug Administration (FDA) raised the issue at a site inspection in December, leading to a BioXcel investigation. CEO Vimal Mehta said it was more of a documentation issue and did not involve falsification of side effects, adding that the company may do its own independent audit regarding the trial data.
Source Fool.com
